Abstract: Wax-based compositions for making barrier layers used in oral treatment devices are thermally stable when formed into a flat sheet or three-dimensional article to a temperature of at least 45° C. and are plastically deformable at room temperature (25° C.). The wax-based compositions include a wax fraction homogeneously blended with a polymer fraction. The wax fraction includes at least one wax and the polymer fraction includes at least one polymer selected such that, when the at least one wax and at least one polymer are homogeneously blended together, they yield a wax-based composition having the desired properties of thermal stability and plastic deformability. Barrier layers and oral treatment devices made from such wax-based compositions are dimensionally stable to a temperature of at least 40° C. without external support and can be plastically deformed in a user's mouth to become at least partially customized to the size and shape of user's unique dentition.

Abstract: Various methods and devices are provided for allowing multiple surgical instruments to be inserted into sealing elements of a single surgical access device. The sealing elements can be movable along predefined pathways within the device to allow surgical instruments inserted through the sealing elements to be moved laterally, rotationally, angularly, and vertically relative to a central longitudinal axis of the device for ease of manipulation within a patient's body while maintaining insufflation.

Abstract: A steerable delivery system is provided for delivering a replacement heart valve to a native heart valve location. The steerable delivery system includes an outer sheath assembly having a capsule along a distal end portion for retaining the replacement heart valve in a compressed configuration. The capsule is constructed to provide both compression resistance and flexibility. The capsule may be formed with an outer polymer layer, a metal middle layer located on a radially inner surface of the outer polymer layer, and an inner liner located on a radially inner surface of the metal middle layer. A fluoroelastomer layer is provided for bonding the inner liner to the metal middle layer. The metal middle layer is preferably a metal hypotube.

Abstract: An adjustable tensioning device capable of providing and holding high tensions needed for medical devices, prosthetics, and orthotics.

Abstract: An assembly for a body joint orthotic that generates a distraction force to the joint that can be synchronized with the flexion of said joint. The hinge may be polycentric or unicentric. For a polycentric hinge, the distraction can be generated by varying the distance between the axes of rotation of the two pivot points. For a unicentric hinge, the distraction can be generated by increasing the length of at least one of the arms that connects the strapping element which holds the orthotic to the limb or body part to the hinge. The synchronization of the amount of distraction to the angle of flexion may be achieved by purely mechanical mechanisms or involving a motor.

Abstract: An apparatus and methods for making for shoulder orthoses, which can control the position of the humeral head/arm relative to the shoulder joint by adjusting tension across the joint. The orthoses allows the user to modify the direction and magnitude of force applied while wearing the orthosis. The orthosis may contain cams or extensions to direct and amplify the force around the joint towards a specific range of motion. The orthoses can be made from digitally imaging joints and then partially or fully automating the design of orthosis.

Abstract: A multi-axis rotation control ankle brace, wherein the direction and magnitude of force can be controlled around three axes of the ankle joint through an adjustable tensioning apparatus. The device may be applied to address conditions such as chronic ankle instability, foot drop, or osteoarthritis by providing such forces around the joint as an external-muscle tendon system to improve function, reduce pain, or restore mobility of the user. While more are contemplated herein, five preferred embodiments are specifically disclosed in the current application. Three preferred embodiments comprise a proximal portion and a distal portion, wherein the proximal portion is anchored above the ankle joint and houses, in aspects, the adjustment mechanism. The proximal portion is connected to the distal portion by tensioning or compressive elements, through which threes can be controlled by the user via the adjustment mechanism.

Abstract: An adjustable tension knee brace for unloading weight from a knee joint afflicted with osteoarthritis, thus reducing pain and improving mobility, comprising: an upper and lower frame connected by an unloading hinge assembly, optionally comprising a sensor and processor allowing for remote or automatic control of brace tension. In embodiments, the brace includes a user mechanism that is capable of adjusting a tensioning element while the brace is being worn. In other embodiments, electronic motors, sensors, and indicators may be included in the brace to improve brace performance and user interaction.

Abstract: An adjustable tensioning device capable of providing and holding high tensions needed for medical devices, prosthetics, and orthotics.

Abstract: A pivoting hinge assembly for an orthotic device for a knee joint afflicted with osteoarthritis, thus reducing pain and improving mobility, comprising: a proximal subunit, a distal subunit, an energy storage element capable of generating significant forces around the joint, and a tension adjustable geared hinge assembly. Four embodiments are disclosed of hinge assemblies useable with the knee brace, or other types of braces. The hinge assemblies comprise: two subunits housing intermeshed gears, and at least one elastic band extending between the hinge subunits over a cam surface above the gears. In three embodiments, U-shaped connectors secure the subunits and gears together, and the subunits may comprise a user mechanism that adjusts the elastic band's tension and thus the amount of weight unloaded, then releases it.

Abstract: A multi-axis rotation control ankle brace, wherein the direction and magnitude of force can be controlled around three axes of the ankle joint through an adjustable tensioning apparatus. The device may be applied to address conditions such as chronic ankle instability, foot drop, or osteoarthritis by providing such forces around the joint as an external-muscle tendon system to improve function, reduce pain, or restore mobility of the user. While more are contemplated herein, five preferred embodiments are specifically disclosed in the current application. Three preferred embodiments comprise a proximal portion and a distal portion, wherein the proximal portion is anchored above the ankle joint and houses, in aspects, the adjustment mechanism. The proximal portion is connected to the distal portion by tensioning or compressive elements, through which forces can be controlled by the user via the adjustment mechanism.

Abstract: An adjustable tensioning device capable of providing and holding high tensions needed for medical devices, prosthetics, and orthotics.

Abstract: An adjustable knee ankle foot orthosis for unloading weight from a knee joint afflicted with osteoarthritis, thus reducing pain and improving mobility, comprising: an upper and lower frame connected by an unloading hinge assembly, optionally comprising a sensor and processor allowing for remote or automatic control of brace tension. In embodiments, the brace includes a user mechanism that is capable of adjusting a tensioning element while the brace is being worn. In other embodiments, electronic motors, sensors, and indicators may be included in the brace to improve brace performance and user interaction.

Abstract: An adjustable tension knee brace for unloading weight from a knee joint afflicted with osteoarthritis, thus reducing pain and improving mobility, comprising: an upper and lower rigid posterior portion, anterior straps, and a tension adjustable geared hinge assembly. Four embodiments are disclosed of hinge assemblies useable with the knee brace, or other types of braces. The hinge assemblies comprise: two subunits housing intermeshed gears, and at least one elastic band extending between the hinge subunits over a cam surface above the gears. In three embodiments, U-shaped connectors secure the subunits and gears together, and the subunits may comprise a user mechanism that adjusts the elastic band's tension and thus the amount of weight unloaded, then releases it. Another embodiment comprises a core bracket to protect the band(s) and a mechanism to compress the elastic band at various points to increase the amount of tension, and with a quick release mechanism.

Abstract: An adjustable knee ankle foot orthosis for unloading weight from a knee joint afflicted with osteoarthritis, thus reducing pain and improving mobility, comprising: an upper and lower frame connected by an unloading hinge assembly, optionally comprising a sensor and processor allowing for remote or automatic control of brace tension. In embodiments, the brace includes a user mechanism that is capable of adjusting a tensioning element while the brace is being worn. In other embodiments, electronic motors, sensors, and indicators may be included in the brace to improve brace performance and user interaction.

Abstract: A device to prevent migration of an orthotic, such as an unloading joint brace.

Abstract: An automated method for generating digital specifications for the manufacture of a custom joint orthosis from a 3D model or scan. A 3D model or scan of a body or body part can be captured using a scanning device that generates a 3D point-cloud data set. A reference point is selected as an origin that measures the distance between it and critical points, either by the user or automatically through machine learning applications of feature identification. Additional biometric data, medical information, or user preference information may be incorporated to generate digital specifications for the manufacture of a supportive brace or an orthotic device. A use of the invention for medical diagnostic applications is also described.

Abstract: An automated method for generating digital specifications for the manufacture of a custom joint orthosis from a 3D model or scan. A 3D model or scan of a body or body part can be captured using a scanning device that generates a 3D point-cloud data set. A reference point is selected as an origin that measures the distance between it and critical points, either by the user or automatically through machine learning applications of feature identification. Additional biometric data, medical information, or user preference information may be incorporated to generate digital specifications for the manufacture of a supportive brace or an orthotic device. A use of the invention for medical diagnostic applications is also described.

Abstract: A multi-axis rotation control ankle brace, wherein the direction and magnitude of force can be controlled around three axes of the ankle joint through an adjustable tensioning apparatus. The device may be applied to address conditions such as chronic ankle instability, foot drop, or osteoarthritis by providing such forces around the joint as an external-muscle tendon system to improve function, reduce pain, or restore mobility of the user. While more are contemplated herein, five preferred embodiments are specifically disclosed in the current application. Three preferred embodiments comprise a proximal portion and a distal portion, wherein the proximal portion is anchored above the ankle joint and houses, in aspects, the adjustment mechanism. The proximal portion is connected to the distal portion by tensioning or compressive elements, through which forces can be controlled by the user via the adjustment mechanism.

Abstract: An automated method for applying specific geometric constraints to a starter file and considering external specifications outside of fit to achieve an optimized, restorative joint brace or orthotic device. External specifications may include indications of the patient, biometric data, data from prescribing doctors, X-ray data, MRI data, joint geometry to restore optimized function, and envelope of motion. After the fitting process, the starter file undergoes a process of exact commands in order to finish and/or add additional features. With a vertical integration from scanning an object to producing the custom fitted device, the product can be manufactured at scale more rapidly and at lower cost, improving access to superior devices at a reasonable price to the consumer.